Application of WHO International Biological Reference Standards to evaluate commercial serological tests for chronic Chagas disease
Mem. Inst. Oswaldo Cruz
;
115: e200214, 2020. tab, graf
Artículo
en Inglés
| LILACS, SES-SP
| ID: biblio-1135280
ABSTRACT
BACKGROUND Chagas disease, resulting from Trypanosoma cruzi infections, continues to be a health concern mainly in Latin American countries where the parasite is endemic. The laboratory diagnosis of a chronic infection is determined through serological assays for antibodies against T. cruzi and several tests are available that differ in key components, formats and methodologies. To date, no single test meets the criteria of a gold standard. The situation is further complicated by the difficulties associated with performance comparisons between different immunoassays or methodologies executed at different times and geographical areas. OBJECTIVE To improve the diagnosis of Chagas disease, the WHO coordinated the development of two International Biological Reference Standards for antibodies against anti-T. cruzi NIBSC 09/186 and NIBSC 09/188 that respectively represent geographical regions with the highest prevalence of TcII and TcI lineages of the parasite. METHODS The principle goal of this study was to verify the behavior of these standards when assayed by several commercially available serological tests that employ different methods to capture and detect human anti-T. cruzi antibodies. FINDINGS AND MAIN CONCLUSIONS The results reinforce the recommendation that these standards be considered for performance evaluations of commercialised immunoassays and should be an integral step in the development of new test components or assay paradigms.
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Trypanosoma cruzi
/
Pruebas Serológicas
/
Enfermedad de Chagas
Tipo de estudio:
Estudio diagnóstico
/
Guía de Práctica Clínica
/
Factores de riesgo
Límite:
Humanos
Idioma:
Inglés
Revista:
Mem. Inst. Oswaldo Cruz
Año:
2020
Tipo del documento:
Artículo
Institución/País de afiliación:
Fundação Oswaldo Cruz-Fiocruz/BR
/
Sociedade Brasileira de Análises Clínicas/BR
/
World Health Organization/CH
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